The proposed study evaluates the effectiveness of preventive drug (beta-blocker) therapy and non-drug (behavioral migraine management) therapies for frequent migraine, both separately and when combined.
The specific aims are to: (1) Evaluate the separate and combined effects of Preventive Drug Therapy and limited-contact Behavioral Migraine Management, with reference to Placebo in a (n=220) prospective outcome study; (2) Evaluate the effectiveness of these treatments of individuals with frequent (4-15 migraine days/month) disabling (above the population median in disability) migraine; (3) Evaluate the effects of these treatments on multiple outcome measures, including migraine activity, disability, quality of life, psychological symptoms and beliefs about migraines; (4) Evaluate the effects of these treatments on the use, effectiveness and cost of acute (5HT1 antagonist) therapy; (5) Evaluate intermediate (6 months) and long-term (1-year) treatment effects. Examine psychological variables hypothesized to be associated with the maintenance of treatment effects. Two hundred twenty patients meeting International Headache Society (Olesen, 1988) diagnostic criteria for migraine (w or w/o aura) and who experience frequent (4 to 15 migraine/days month) and disabling (above the median of migraine sufferers in disability) migraine will participate in the following three phases of this study: (1) pretreatment evaluation that includes structured diagnostic and psychosocial interview, neurological evaluation, psychosocial testing and at least 5 weeks baseline daily monitoring of migraine activity, migraine-related disability and medication use; (2) a three-month treatment (administration/dose adjustment) phase where standard acute therapy plus one of the following four preventive therapies are administered in a 2 x 2 factorial design: Preventive Drug Therapy with beta-blockers, or Preventive Drug Therapy with placebo, or Behavioral Migraine Management Therapy + beta blockers, or Behavioral Migraine Management + placebo and, (3) a 12-month long evaluation phase where continuing care is provided and treatment efficacy is assessed at 1-month, 6-months and 12-months follow follow-up evaluations (with neurological & psychosocial evaluations and 5 additional weeks of daily headache, disability and medication recordings).
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